SURGICAL DRAPES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CATHETER, SINGLE PUNCTURE Y

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)

FENESTRA HOOK

FDA 510(k)

FDA Class 2 ·Radiology

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Co2 Laser System, Models: PureLase And VanLase

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·VASCUTEK GELSOFT(TM) VASCULAR GRAFT

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·VASCUTEK GELSOFT(TM) VASCULAR GRAFT

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·VASCUTEK GELSEAL(TM) VASCULAR GRAFT

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·VASCUTEK GELSEAL(TM) VASCULAR GRAFT

Accessories, Solution, Ultrasonic Cleaners For Lenses

FDA Pre-Market Approval

FDA Class 2 ·UNIZYME(TM) ENZYMATIC CLEANER

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·GELSEAL TM TRIAXIAL VASCULAR GRAFT

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II

DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip

FDA 510(k)

FDA Class 2 ·Radiology

VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips

FDA 510(k)

FDA Class 2 ·Radiology

FlexBoardTM, EagleBoardTM, BreastBoard SXTM

FDA 510(k)

FDA Class 2 ·Radiology

Analyzer, Medical Image

FDA classification

FDA Class 2 ·Analyzer, Medical Image

Media, Reproductive, Exempt

FDA classification

FDA Class 2 ·Media, Reproductive, Exempt

Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

FDA classification

FDA Class 2 ·Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers